Global pharmaceutical companies are making progress in developing messenger ribonucleic acid (mRNA) cancer vaccines and immuno-oncology combinations.

Recently, Regeneron and BioNTech confirmed efficacy in a Phase II clinical trial for melanoma.

Moderna, a company specializing in the development of mRNA vaccines, has also shown promise in melanoma and head and neck cancer using its vaccine in combination with the immuno-oncology drug Keytruda.

In Korea, LG Chem, ImmuneOncia, and others are developing new mRNA and immuno-oncology drug combinations.

A cancer vaccine activates the immune system by administering cancer cell antigens to patients, rather than being a preventive concept.

Like a vaccine, it has a mechanism that activates the immune response and causes cancer cells to kill themselves.

Major pharmaceutical and biotech companies are combining immuno-oncology drugs and antibody-drug conjugates (ADCs) focusing on maximizing the treatment effect rather than cancer prevention to increase their commercialization potential.

#i According to industry sources on the 15th, a cancer vaccine and immuno-oncology drug combination using the cancer vaccine developed by the German BioNTech had demonstrated efficacy in a Phase II study in melanoma patients.

The trial evaluated the clinical activity of BioNTech's mRNA vaccine BNT111 in combination with Regeneron's PD-1 immuno-oncology drug Libtayo (cemiplimab).

BNT111 is a cancer vaccine that enhances T-cell responses to 4 antigens (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE) expressed in melanoma patients.

In clinical trials, the BNT111 and Libtayo combination demonstrated a statistically significant improvement in overall response rate (ORR).

The specifics will be presented at an upcoming international conference.

BioNTech is also currently conducting a Phase II clinical trial comparing the efficacy and safety of another cancer vaccine candidate, Autogene cevumeran, with Roche's immuno-oncology drug Tecentriq (atezolizumab).

Autogene cevumeran is a therapeutic personalized cancer vaccine candidate that screens and encodes up to 20 patient-specific cancer mutations that can act as neoantigens.

The trial evaluated the efficacy of the Autogene cevumeran + Tecentriq combination with the FOLFIRINOX regimen ((luorouracil+leucovorin+irinotecan+oxaliplatin).

In addition to melanoma, Moderna is also exploring the potential of combining its cancer vaccine candidate mRNA-4157 with MSD's immuno-oncology drug Keytruda for patients with head and neck cancer.

The company recently announced clinical results from a study on patients with head and neck cancer The trial evaluated the efficacy and safety of Moderna’s candidate mRNA-4157 in combination with MSD's immuno-oncology drug Keytruda (pembrolizumab) in 22 patients with human papillomavirus (HPV)-negative head and neck squamous cell carcinoma.

In the trial, the objective response rate (ORR) for the mRNA-4157 plus Keytruda combination was 27%, compared with the 18% achieved in the Keytruda monotherapy arm.

Overall survival (OS) for the combination was 24.6 months, which was longer than the 9.8 months achieved in the Keytruda monotherapy arm.

Moderna is currently conducting a Phase III clinical trial for the mRNA-4157 plus Keytruda combination in melanoma.

In an ongoing Phase II trial in melanoma patients, mRNA-4157 plus Keytruda was shown to reduce the risk of recurrence or death by 49% compared to Keytruda monotherapy.

Domestic companies such as Yuhan Corp and ImmuneOncia start developing mRNA+ immuno-oncology drugs# The domestic pharmaceutical bio-industry is also confirming the potential of the mRNA and immuno-oncology combination therapy.